SMBD - Jewish General Hospital Research Ethics Committee
Northeast Ohio Medical University
Institutional Review Board (IRB) Application
Office of Research and Sponsored Programs
Continuation Request Form
To request a continuation beyond the initial period of approval, please submit 1 copy with original signatures of each of the following: (1) this completed form; (2) the study protocol; and (3) any consent forms; to the Office of Research and Sponsored Programs, room G-235 at NEOMED. This submission must be received at least two weeks before the expiration for studies that received expedited approval and 3 weeks before the expiration of the study for those that received full board approval. You may append additional information to this sheet. A minimum of an annual review is required for ALL studies, however, the IRB may require more frequent review in some instances. Failure to seek Committee approval for study continuation leads to administrative termination/closureof the project by the IRB.
I. Investigator’s Name / Dept. / *Human Subjects Training Certificate Date / Telephone / E-mail / Role on project (PI or Co-PI)*Human Subjects Training Certificates are current for 3 years from date of completion. Personnel not having a current certificate are not permitted to continue on a project until a current certificate has been sent to the IRB Office.
Ia. Staff Contact / Research Coordinator / Telephone / FAX / Location and Room #
II. NEOMED PROTOCOL NUMBER:
III. TITLE OF PROTOCOL
III. DATE OF FIRSTAPPROVAL: From to
IV. DATE OF LAST APPROVAL: From to
_
- Status of protocol:
This study is active (still recruiting, conducting study procedures, or receiving human tissue samples from hospital sources or CHTN)
This study is in data analysisclosed to recruitment and all study procedures completed)
This study is dormant (initially started, but not progressing)
If dormant, reason: accrual funding other
If dormant, do you expect to activate the protocol within the next 4 months? Yes No
- Total Number of participants enrolled (or tissue samples received) at this site since last approval:
- Total Number of participants enrolled(or number of tissue samples received) at this site
since originally approval:
_
4. Total Number of participants withdrawn since last approval period:
a) Specify reason(s) for participants withdrawal: ______
5.Projected date of study completion including data analysis:
a) Projected date of completion of study recruitment or date which you will not longer require tissue samples:
______.
- Are there any new findings or knowledge relevant to the potential benefits and risks as originally stated, which may influence participants' willingness to participate? Yes No N/A
If the answer to Question 6 is yes, describe:
- a) Has this new information has been communicated to patients?Yes NoN/A
- Have there been any changes in the study procedures? Yes No
a) If yes, please specify:
b) If yes, were these reported to the IRB?Yes No
9. Have there been any changes to the Consent Form or protocol?Yes No
a) If yes, please specify:
b) If yes, were these reported to the IRB?Yes No
10. Have there been any changes in inclusion / exclusion criteria of study participants?Yes No N/A
a) If yes, describe:
11. Have there been any changes in the project personnel, either additions or deletions? Yes No N/A
If yes, please list these changes:
12.Have there been any serious adverse reactions since the last approval date?Yes No N/A
a) If yes, how many:______
b) Were these reported to the IRB? Yes No
c) If no, submit a list of serious adverse events not reported with this report.
13. Any adverse reactions?Yes No N/A
a) If yes, how many:
b) If yes, submit a list of adverse events not reported with this report.
14. Have there been any publications using results of this study? If so, please list:
Principal Investigator SignatureDate
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For IRB Use Only
Reviewer’s Recommendation
Project May Continue as Presented. Review again in 12 months.
Project May Continue but further evaluation of the project is warranted,
Completed:Project Has Been Successfully Completed.
Completed: Project Never Received Funding.
Project Should Be Closed (explain below)
______
______
Reviewer Date
Update 9-18-13